A medical implant is described and, more particularly, a medical implant for use in joint or segmental bone defects for deformity correction with or without obtaining arthrodesis.
Implants may be used in humans or animals to support or secure one or more bones. Once implanted, the implant may provide support between the bones and bone growth may take place around and through the implant to at least partially fuse the bones for long-term support.
There is a need for an improved medical implant for use in body areas, such as bones of the foot and ankle.
An implant is provided for use in an ankle joint between reconditioned end surfaces established on a distal end of an upper tibia bone and an opposing lower talus bone. The implant comprises a substantially porous rigid component adapted to be anchored against the upper tibia reconditioned end surface and the lower talus reconditioned end surface. The component defining an opening therethrough. An intramedullary nail is configured to pass through the opening in the component when the nail is driven through the talus and into the tibia.
A method of securing an ankle joint is also provided. The method comprises the steps of reconditioning end surfaces on a distal end of an upper tibia bone and an opposing lower talus bone of the ankle joint. A substantially porous rigid component is positioned against the upper tibia reconditioned end surface and the lower talus reconditioned end surface. The component defining an opening therethrough. An intramedullary nail configured to be driven through the through the talus and the opening in the component and into the tibia.
For a more complete understanding of the bone implant, reference should now be had to the embodiments shown in the accompanying drawings and described below. In the drawings:
Certain terminology is used herein for convenience only and is not to be taken as a limitation on the invention. For example, words such as “upper,” “lower,” “left,” “right,” “horizontal,” “vertical,” “upward,” and “downward” merely describe the configuration shown in the FIGs. Indeed, the components may be oriented in any direction and the terminology, therefore, should be understood as encompassing such variations unless specified otherwise.
Referring now to
In one embodiment, the web structure 22 is formed with interconnected triangular-shaped building blocks. The result is a web structure 22 formed from a pattern of triangularly-shaped geometrical building blocks. The triangularly-shaped building blocks may form tetrahedrons that may also be used as building blocks. Other patterns from the triangles are also contemplated. Each tetrahedron may include four triangular faces in which three of the four triangles meet at each vertex. At least two of the plurality of tetrahedrons are coupled together via one or more common components connecting two respective vertices on each of the two tetrahedrons such that two tetrahedrons share a common unit to form a hexahedron.
In one embodiment, the porous web structure 22 is configured to form a substantially spherical structure as shown in
The implant 20 may be formed from a biocompatible material such as a titanium alloy (e.g., y-titanium aluminides), cobalt, chromium, stainless steel, polyetheretherketone (PEEK), ceramics, or other suitable material. The implant 20 may be made through a rapid prototyping process (e.g., electron beam melting (EBM) process). Other processes are also possible, such as injection molding, casting, sintering, selective laser sintering (SLS), direct metal laser sintering (DMLS), etc). SLS may include laser-sintering of high-performance polymers such as that provided by EOS of North America, Inc., headquartered in Novi, Mich., U.S.A. High-performance polymers may include various forms of PEEK (e.g., HP3 having a tensile strength of up to about 95 mega Pascal (MPa) and a Young's modulus of up to about 4400 MPa and continuous operating temperature between about 180° C. (356° F.) and 260° C. (500° F.)). Other materials may include PA 12 and PA 11 provided by EOS of North America, Inc. Multiple parts may be cast or injection molded and joined together (e.g., through welding, melting, etc.). For example, individual components 24 forming the implant 20 may be generated separately (e.g., by casting, injection molding, etc.) and welded together to form the implant 20. The porous web structure 22 may be made according to the disclosure of International Application No. PCT/US2012/045717, filed Jul. 6, 2012, and published Jan. 10, 2013, as International Publication No. WO 2013/006778, the contents of which are hereby incorporated by reference in their entirety.
In another embodiment shown in
The implant 20, 50 may include a top face 26 and an opposed bottom face 28 wherein at least a portion of the top face 26 and the bottom face 28 are generally parallel to one another. In use, the top and bottom faces 26, 28 are configured to be disposed in contact, or near contact, of an adjacent bony structure for contacting the bony structure during use to adhere or couple with the adjacent structure when implanted. As depicted, for example, the implant 20, 50 is intended to sandwich between two adjacent bony structures interfacing with bone structure of a foot and ankle joint 34. The top contact face 26 may couple to a portion of the first bony structure disposed above implant 20 and the bottom contact face 28 may couple to the second bony structure disposed below implant 20.
The web structure 22 defines openings configured to define open volume to enable bone growth through the openings of the web structure 22, thereby enhancing coupling of the implant 20 to the adjacent bony structure. At least a portion of the web structure 22 is in contact, or near contact, with the adjacent bony structure, thereby enabling bone growth to extend into or through at least a portion of open volume of the web structure 22 such that the bone growth interlocks with the web structure 22 of the implant 20. The interlocking of the bone growth and the web structure 22 may rigidly fix the implant 20 in a fixed location relative to the bony structure. For example, a web structure 22 may define an open space for bone growth therethrough, thereby enabling bone through growth to interlock the bone structure and the web structure 22 with one another to couple the implant 20 to the bony structure at or near the contact surface. Such interlocking bone through growth may inhibit movement between the implant 20 and the bony structure, which could otherwise lead to loosening, migration, subsidence, or dislodging of the implant 20 from the intended position.
The web structure 22 of the implant 20 may also provide surface area for bone graft fusion. For example, the voids in the web structure 22 of the implant 20 may be filled with, or surfaces of the web structure 22 may be coated with, bone grafting material, a biologic, growth factor or the like. The web structure 22 extending throughout the implant 20 may add additional surface area on the surface of the components 24 to fuse to the bone graft material and prevent the bone graft material from loosening or migrating from the implant 20. In some embodiments, the web structure 22 may also support and facilitate bone in-growth. For example, adjacent bone in an ankle joint may grow over at least a portion of the components 24 of the implant 22. The bone growth and engagement between the bone growth and the implant 20 may further stabilize the implant. In some embodiments, the surfaces of the implant 20 may be formed with a rough surface to assist in bone in-growth adhesion.
At least a portion of the open volume of the web structure 22 of the implant 20 may be filled with bone growth material. For example, cancellous bone may be packed into the openings internally of the implant 20. In some embodiments, at least a portion of the surfaces of implant 20 may be coated or treated with a material intend to promote bone growth or bone adhesion or an antimicrobial agent to prevent infections. For example, in some embodiments, the surface of the web structure 22 may be coated with a biologic or a bone growth factor. For example, the biologic or growth factor may be physically secured to the web structure 22 in a central portion of the implant 20 provided there is the physical attachment of the biologic or growth factor. The biologic may include a coating, such as hydroxyapatite, bone morphaginic protein (BMP), insulin-like growth factors I and II, transforming growth factor-beta, acidic and basic fibroblast growth factor, platelet-derived growth factor, or similar bone growth stimulant that facilitates good biological fixation between the bone growth and a surface of the implant 20. The bone growth factor may include a naturally occurring substance capable of stimulating cellular growth, proliferation and cellular differentiation (e.g., a protein or steroid hormone).
As shown in the
In the embodiment of the implant having individual components 24 shown in
A method is provided that includes the steps of providing an opening in a foot or ankle 34 of a human, and installing into the opening the implant 20, 44, 50, 54. The implant location is first prepared, including surgical dissection for forming an opening proximate the foot or ankle 34 to the level of proposed implantation. Next, a bone bed can be prepared from the adjacent bony structure either by using a spherical reaming device or using a saw and osteotomes. The bone bed may be formed in either a joint or within a single bone. Bone graft material may be packed in the bone bed or within the porous web structure 22 of the implant 20. The implant 20 is then inserted into the bone bed. The implant 20 may be incorporated into the end surfaces established between an upper tibia bone 36 and an opposite and lower talus bone 38. The shape of at least a portion of the implant 20 allows the bone or the joint surface on either side of the implant 20 to be placed in a preferred position, for example, to correct a deformity.
In some embodiments, inserting the implant 20 includes positioning the implant 20 adjacent the boney structure, aligning the web structure 22 with a complementary portion of the boney structure, or advancing a contact surface toward the boney structure such that at least the web structure 22 is in contact or near contact with the boney structure. In some embodiments, the implant 20 may be advanced until the contact surface is in contact or near contact with the boney structure, such that at least portion or substantially all of the web structure 22 is disposed in the boney structure.
The implant 20 then may, or may not be, fixed in place. In one embodiment, an intramedullary nail 32 is inserted into the heel and through the passage 30 in the web structure 22 of the implant 20. The nail 32 is driven into the end of the tibia 36 for fusing the foot and ankle joint 34 (
Once the implant is positioned in the foot and ankle joint 34, the access point to the implant site may be closed using sutures or other closure devices.
Although the bone implant has been shown and described in considerable detail with respect to only a few exemplary embodiments thereof, it should be understood by those skilled in the art that I do not intend to limit the invention to the embodiments since various modifications, omissions and additions may be made to the disclosed embodiments without materially departing from the novel teachings and advantages, particularly in light of the foregoing teachings. Accordingly, I intend to cover all such modifications, omission, additions and equivalents as may be included within the spirit and scope of the bone implant as defined by the following claims. In the claims, means-plus-function clauses are intended to cover the structures described herein as performing the recited function and not only structural equivalents but also equivalent structures. Thus, although a nail and a screw may not be structural equivalents in that a nail employs a cylindrical surface to secure wooden parts together, whereas a screw employs a helical surface, in the environment of fastening wooden parts, a nail and a screw may be equivalent structures.
This application is a continuation application of U.S. patent application Ser. No. 15/162,525, filed May 23, 2016, which is related to U.S. provisional application No. 62/165,376, filed May 22, 2015, entitled “JOINT OR SEGMENTAL BONE IMPLANT FOR DEFORMITY CORRECTION”, naming Samuel Adams as the inventor, the contents of both of which are incorporated herein by reference in their entirety.
Number | Name | Date | Kind |
---|---|---|---|
4820305 | Harms et al. | Apr 1989 | A |
4936848 | Bagby | Jun 1990 | A |
5281226 | Davydov et al. | Jan 1994 | A |
5609367 | Eusebi et al. | Mar 1997 | A |
5702451 | Biedermann et al. | Dec 1997 | A |
6086613 | Camino et al. | Jul 2000 | A |
6193755 | Metz-Stavenhagen et al. | Feb 2001 | B1 |
6193756 | Studer et al. | Feb 2001 | B1 |
6200348 | Biedermann et al. | Mar 2001 | B1 |
6206924 | Timm | Mar 2001 | B1 |
6579293 | Chandran | Jun 2003 | B1 |
6585770 | White et al. | Jul 2003 | B1 |
6663669 | Reiley | Dec 2003 | B1 |
6673116 | Reiley | Jan 2004 | B2 |
6706924 | Schelhaas et al. | Mar 2004 | B2 |
6902581 | Walkenhorst et al. | Jun 2005 | B2 |
6931812 | Lipscomb | Aug 2005 | B1 |
7087200 | Taboas et al. | Aug 2006 | B2 |
7244273 | Pedersen et al. | Jul 2007 | B2 |
7314488 | Reiley | Jan 2008 | B2 |
7641697 | Reiley | Jan 2010 | B2 |
7717920 | Reiley | May 2010 | B2 |
7855062 | Harlow et al. | Dec 2010 | B2 |
8062365 | Schwab | Nov 2011 | B2 |
8114647 | Harlow et al. | Feb 2012 | B2 |
8278094 | Harlow et al. | Oct 2012 | B2 |
8292967 | Brown et al. | Oct 2012 | B2 |
8354258 | Jung et al. | Jan 2013 | B2 |
8367384 | Harlow et al. | Feb 2013 | B2 |
8430930 | Hunt | Apr 2013 | B2 |
8430950 | Kuske et al. | Apr 2013 | B2 |
8485820 | Ali | Jul 2013 | B1 |
8492143 | Harlow et al. | Jul 2013 | B2 |
RE44501 | Janna et al. | Sep 2013 | E |
8532806 | Masson | Sep 2013 | B1 |
8545572 | Olson | Oct 2013 | B2 |
8682619 | Amodei et al. | Mar 2014 | B2 |
8709089 | Lang et al. | Apr 2014 | B2 |
8734823 | Amodei et al. | May 2014 | B2 |
8808303 | Stemniski et al. | Aug 2014 | B2 |
8808389 | Reiley | Aug 2014 | B2 |
8900865 | Harlow et al. | Dec 2014 | B2 |
8906022 | Krinke et al. | Dec 2014 | B2 |
8975074 | Harlow et al. | Mar 2015 | B2 |
8999711 | Harlow et al. | Apr 2015 | B2 |
9005943 | Harlow et al. | Apr 2015 | B2 |
9005944 | Harlow et al. | Apr 2015 | B2 |
9020788 | Lang et al. | Apr 2015 | B2 |
9023630 | Harlow et al. | May 2015 | B2 |
9061075 | Harlow et al. | Jun 2015 | B2 |
9066764 | Perez | Jun 2015 | B2 |
9271845 | Hunt et al. | Mar 2016 | B2 |
9364330 | Lindsey et al. | Jun 2016 | B2 |
9364896 | Christensen et al. | Jun 2016 | B2 |
9421108 | Hunt | Aug 2016 | B2 |
9456901 | Jones et al. | Oct 2016 | B2 |
9545317 | Hunt | Jan 2017 | B2 |
9549823 | Hunt et al. | Jan 2017 | B2 |
9572669 | Hunt et al. | Feb 2017 | B2 |
9636226 | Hunt | May 2017 | B2 |
9636276 | Woolston | May 2017 | B2 |
9642632 | Stemniski et al. | May 2017 | B2 |
9724203 | Nebosky et al. | Aug 2017 | B2 |
9757235 | Hunt et al. | Sep 2017 | B2 |
9814595 | Biedermann et al. | Nov 2017 | B2 |
9890827 | Schaedler et al. | Feb 2018 | B2 |
9987137 | Hunt et al. | Jun 2018 | B2 |
9993277 | Krinke et al. | Jun 2018 | B2 |
9999516 | Hunt | Jun 2018 | B2 |
10039557 | Stemniski et al. | Aug 2018 | B2 |
10045854 | Adams | Aug 2018 | B2 |
10064726 | Wei | Sep 2018 | B1 |
10070962 | Moore et al. | Sep 2018 | B1 |
10098746 | Moore et al. | Oct 2018 | B1 |
10130485 | Biedermann et al. | Nov 2018 | B2 |
10166033 | Reiley et al. | Jan 2019 | B2 |
10182832 | Saltzman et al. | Jan 2019 | B1 |
10213309 | Lindsey et al. | Feb 2019 | B2 |
20050015154 | Lindsey et al. | Jan 2005 | A1 |
20060147332 | Jones et al. | Jul 2006 | A1 |
20100174377 | Heuer | Jul 2010 | A1 |
20110125284 | Gabbrielli et al. | May 2011 | A1 |
20110172826 | Amodei et al. | Jul 2011 | A1 |
20110200478 | Billiet et al. | Aug 2011 | A1 |
20110313532 | Hunt | Dec 2011 | A1 |
20130030529 | Hunt | Jan 2013 | A1 |
20130090739 | Linares et al. | Apr 2013 | A1 |
20130101637 | Harlow et al. | Apr 2013 | A1 |
20130123935 | Hunt et al. | May 2013 | A1 |
20130158672 | Hunt | Jun 2013 | A1 |
20130218278 | Wolfe et al. | Aug 2013 | A1 |
20140121776 | Hunt | May 2014 | A1 |
20140277575 | Landgrebe et al. | Sep 2014 | A1 |
20140277576 | Landgrebe et al. | Sep 2014 | A1 |
20140288649 | Hunt | Sep 2014 | A1 |
20140288650 | Hunt | Sep 2014 | A1 |
20150064146 | Harlow et al. | Mar 2015 | A1 |
20150258735 | O'Neill et al. | Sep 2015 | A1 |
20150282946 | Hunt | Oct 2015 | A1 |
20160089245 | Early et al. | Mar 2016 | A1 |
20160287388 | Hunt et al. | Oct 2016 | A1 |
20160338842 | Adams | Nov 2016 | A1 |
20170172752 | Adams | Jun 2017 | A1 |
20170216035 | Hunt | Aug 2017 | A1 |
20170319344 | Hunt | Nov 2017 | A1 |
20170319349 | Kowalczyk | Nov 2017 | A1 |
20170360488 | Kowalczyk et al. | Dec 2017 | A1 |
20180028242 | Parekh et al. | Feb 2018 | A1 |
20180064540 | Hunt et al. | Mar 2018 | A1 |
20180085230 | Hunt | Mar 2018 | A1 |
20180199972 | Krinke et al. | Jul 2018 | A1 |
20180360611 | Adams | Dec 2018 | A1 |
20190060077 | Hunt et al. | Feb 2019 | A1 |
Number | Date | Country |
---|---|---|
2016267051 | Dec 2017 | AU |
2986752 | Dec 2016 | CA |
201164511 | Dec 2008 | CN |
201200499 | Mar 2009 | CN |
107835669 | Mar 2018 | CN |
1800627 | Jun 2007 | EP |
3297553 | Mar 2018 | EP |
373990 | May 1907 | FR |
190118231 | Nov 1901 | GB |
595628 | Dec 1947 | GB |
972282 | Oct 1964 | GB |
201851913 | Apr 2018 | JP |
2004110309 | Dec 2004 | WO |
2005051233 | Jun 2005 | WO |
2008022206 | Feb 2008 | WO |
2011082905 | Jul 2011 | WO |
20110123110 | Oct 2011 | WO |
2013006778 | Jan 2013 | WO |
20130119907 | Aug 2013 | WO |
2016191393 | Dec 2016 | WO |
2016191393 | Dec 2016 | WO |
Entry |
---|
Rasmussen et al., “Implantable Medical Devices With Friction Enhancing Needle Protrusions, and Methods for Making Same Using Additive Manufacturing Techniques”, U.S. Appl. No. 13/530,048, filed Jun. 21, 2012. |
Thimmesch, D., 3D Printed Bone Implant Saves a Virginia Woman's Injured Leg, 3D Printing/Health 3D Printing, Dec. 10, 2014, WRAL.com. |
Surgical Alternatives, International Patent Application No. PCT/US2016/033835, International Search Report and Written Opinion, Aug. 26, 2016. |
U.S. Appl. No. 15/447,227, Office Action, dated Aug. 11, 2017. |
U.S. Appl. No. 15/447,227, Final Office Action, dated Feb. 23, 2018. |
U.S. Appl. No. 15/162,525, Restriction Requirement, dated Apr. 3, 2017. |
U.S. Appl. No. 15/162,525, Office Action, dated Aug. 10, 2017. |
Adams, Samuel; Final Office Action for U.S. Appl. No. 15/447,227, filed Mar. 2, 2017, dated Jan. 25, 2019, 8 pgs. |
Adams, Samuel; Advisory Action for U.S. Appl. No. 15/447,227, filed Mar. 2, 2017, dated Aug. 13, 2018, 3 pgs. |
Adams, Samuel; Issue Notification for U.S. Appl. No. 15/162,525, filed May 23, 2016, dated Jul. 25, 2018, 1 pg. |
Adams, Samuel; Applicant Initiated Interview Summary for U.S. Appl. No. 15/162,525, filed May 23, 2016, dated Jun. 22, 2018, 3 pgs. |
Adams, Samuel; Notice of Allowance for U.S. Appl. No. 15/162,525, filed May 23, 2016, dated Mar. 22, 2018, 7 pgs. |
Adams, Samuel; International Preliminary Repod on Patentability for serial No. PCT/US2016/033835, filed on May 23, 2016, dated Dec. 7, 2017, 8 pgs. |
Adams, Samuel; Applicant Initiated Interview Summary for U.S. Appl. No. 15/447,227, filed Mar. 2, 2017, dated Nov. 13, 2017, 3 pgs. |
Adams, Samuel; Requirement for Restriction/Election for U.S. Appl. No. 15/447,227, filed Mar. 2, 2017, dated Apr. 3, 2017, 9 pgs. |
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20180360611 A1 | Dec 2018 | US |
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62165376 | May 2015 | US |
Number | Date | Country | |
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Parent | 15162525 | May 2016 | US |
Child | 16102107 | US |